Seven-Year Results for RESILIA Tissue in Bicuspid Aortic Valve Replacement Patients: Age and Valve Size Considerations.

Abstract

Objectives: Patients with bicuspid aortic valve disease requiring surgical aortic valve replacement are often younger and want to avoid lifelong anticoagulation. A multicentre single-arm non-randomized study, the COMMENCE trial, studied outcomes of RESILIA tissue aortic valves in bicuspid aortic valve patients through 7 years of follow-up.

Methods: Of 672 patients who underwent surgical replacement of native aortic valves, 214 had bicuspid and 458 had tricuspid aortic valves. Propensity score analyses with inverse probability of treatment weighting were utilized to minimize bias due to measured confounders. Linear mixed-effect models compared longitudinal changes in haemodynamic parameters.

Results: Patients with bicuspid were significantly younger than those with tricuspid aortic valves-mean age of bicuspid: 59.8 (12.4) vs tricuspid: 70.2 (9.5) years; P < .001; 39/214 (18%) bicuspid aortic valve patients were <50 years old. There was no evidence of structural valve deterioration in any bicuspid aortic valve patients over 7 years of follow-up. At 7 years, there was no significant difference between bicuspid and tricuspid aortic valve patients in propensity score- and age-adjusted survival (91.9% vs 88.1%, respectively; P = .35), stroke, or reoperation. Among bicuspid aortic valve patients <65 years of age, there was no significant difference in prosthetic valve effective orifice areas and mean gradients between 3 months and 7 years postoperatively.

Conclusions: Patients with bicuspid aortic valves had excellent outcomes with RESILIA tissue valves at 7 years with no evidence of structural valve deterioration. These results suggest a durable alternative for carefully selected younger patients wishing to avoid anticoagulation.

Clinical trial registration number: NCT01757665.